MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2024

Event Type  malfunction  

Event Description

The event occurred in usa during treatment.It was reported that the perfusionist flushed the post mo pigtail, which triggered a high priority alarm and zeroed the rpms.The alarm was re-setted and the flow was re-initiated.The patient was without flow less than one minute.The cardio help performed as intended as the flow/bubble sensor intervention was activated and let the pump stop.The customer is requesting a training for the staff.No harm to any person has been reported.Complaint id (b)(4).

Manufacturer Narrative

A getinge service technician will investigate the affected cardio help.A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that the perfusionist flushed the post mo pigtail, which triggered a high priority alarm and zeroed the rpms.The alarm was reset and the flow was re-initiated.The patient was without flow less than one minute.The cardiohelp performed as intended as the flow/bubble sensor intervention was activated and let the pump stop.The failure occurred during treatment.The getinge field service technician confirmed that there will be no service on the cardiohelp device, as the customer did not requested.The customer stated that the cardiohelp did not malfunction, but operated as intended.The customer is requesting a training for the staff.The root cause is an user error, confirmed by the customer.The review of the non-conformities has been performed on 2024-02-15 for the period of 2019-10-23 to 2024-01-23.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2019-10-23.Based on the results the reported failure "pump stop" could be confirmed, but was an user related failure.The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : no evaluation needed, as user error.

Event Description

Complaint id# (b)(4).

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 18579954
• MDR Text Key: 333776916
• Report Number: 8010762-2024-00050
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1